US8172793B2 - Coated medical device - Google Patents
Coated medical device Download PDFInfo
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- US8172793B2 US8172793B2 US11/141,574 US14157405A US8172793B2 US 8172793 B2 US8172793 B2 US 8172793B2 US 14157405 A US14157405 A US 14157405A US 8172793 B2 US8172793 B2 US 8172793B2
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- balloon
- medical device
- paclitaxel
- layer
- stent
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Definitions
- a coated medical device it has become common to treat a variety of medical conditions by temporarily or permanently introducing a coated medical device, and, in particular, a coated medical implanted device partly or completely into the esophagus, trachea, colon, biliary tract, urinary tract, vascular system or other location within a human or veterinary patient.
- Many treatments of the vascular or other systems entail the introduction of a device such as a stent, a catheter, a balloon, a wire guide, a cannula or the like.
- a stent may most simply be considered as a cylinder of relatively short length which opens a body passage or lumen or which maintains a body passage or lumen in an open condition.
- balloons such as angioplasty or dilation balloons are expanded to open a body passage or vessel lumen, thereby causing potential trauma or injury to the expanded passage or vessel.
- PTA percutaneous transluminal angioplasty
- a balloon-tipped catheter is inserted in a patient's artery, the balloon being deflated.
- the tip of the catheter is advanced to the site of the atherosclerotic plaque to be dilated.
- the balloon is placed within or across the stenotic segment of the artery, and then inflated. Inflation of the balloon “cracks” the atherosclerotic plaque and expands the vessel, thereby relieving the stenosis, at least in part.
- bioactive material or “bioactive materials.”.
- bioactive materials any or all of these will be collectively referred to as “a bioactive material” or “bioactive materials.”.
- the specific improvement of the present invention entails attaining a desired surface roughness, or texturing, on the surface of the device by whatever treatment of the surface and applying the bioactive material directly to that roughened or textured surface without the need of any further overlying or containment layer or coating.
- this straightforward expedient yields a coated implantable medical device which is sufficiently durable to withstand the desired implantation without suffering an unacceptable amount of loss (if any) of bioactive material from the device.
- Abrading of the surface of the base material is preferably carried out with an abrasive grit delivered at a pressure under flow of about 5 to about 200 PSI (about 34 to about 1380 KPa) and at a grit feed rate of about 1 to about 1000 g/min.
- Abrading of the surface is preferably carried out so as to yield a textured surface on the base material having a mean surface roughness of about 10 ⁇ in. (about 250 nm) and a surface roughness range between about 1 ⁇ in. and about 100 ⁇ in. (about 25 nm and about 2.5 ⁇ m).
- FIG. 3 depicts another preferred embodiment of the present invention in which a coated medical device such as a coated stent is mounted or positioned on another medical device such as an inflatable balloon with a bioactive material disposed on at least the outer surface of the balloon;
- a coated medical device such as a coated stent is mounted or positioned on another medical device such as an inflatable balloon with a bioactive material disposed on at least the outer surface of the balloon;
- FIG. 4 depicts an enlarged and longitudinally cross-sectioned view of the medical device stent mounted on the medical device balloon of FIG. 3 ;
- FIG. 7 depicts an enlarged cross-section end view of the balloon of FIG. 5 in which the folds of the balloon unfurl during expansion and make contact with the inner surface of a vessel;
- the medical device 10 of the present invention first comprises a structure 12 adapted for temporary or permanent introduction into a human or veterinary patient.
- “Adapted” means that the structure 12 is particularly configured, shaped and sized for such introduction.
- the structure 12 is most preferably configured as a vascular stent adapted for insertion into the vascular system of the patient.
- FIGS. 1 and 2 show only a structure 12 configured as a stent, and more particularly, a vascular stent. More preferably, the structure 12 is configured as a vascular stent such as the “LOGIC” stent, the “V-FLEX PLUS” stent, or the “ACHIEVE” stent, all commercially available from Cook Incorporated, Bloomington, Ind. Such stents are cut from a cannula of suitable material and possess a plurality of interconnected struts allowing the stents to expand upon inflation of a balloon on which they are carried.
- a vascular stent such as the “LOGIC” stent, the “V-FLEX PLUS” stent, or the “ACHIEVE” stent, all commercially available from Cook Incorporated, Bloomington, Ind.
- Such stents are cut from a cannula of suitable material and possess a plurality of interconnected struts allowing the stents to expand upon inflation
- the base material 14 of the structure 12 is preferably non-porous, although the structure 12 itself can be perforate.
- the difference between a porous material and a non-porous but perforate material is a practical one; the relatively smaller open cells of a porous material are of a character and number sufficient to retain an appreciable amount of an applied bioactive material therein, while the relatively larger perforations of a non-porous material are of a character and number which are not sufficient to retain an appreciable amount of an applied bioactive material therein.
- the open cells of a porous material can be considered generally microscopic, while perforations through a non-porous material can be considered generally macroscopic.
- Heparin is a mucopolysaccharide anticoagulant typically obtained from porcine intestinal mucosa or bovine lung. Heparin acts as a thrombin inhibitor by greatly enhancing the effects of the blood's endogenous antithrombin III. Thrombin, a potent enzyme in the coagulation cascade, is key in catalyzing the formation of fibrin. Therefore, by inhibiting thrombin, heparin inhibits the formation of fibrin thrombi.
- a vasodilator such as a calcium channel blocker or a nitrate will suppress vasospasm, which is common following angioplasty procedures.
- Vasospasm occurs as a response to injury of a blood vessel, and the tendency toward vasospasm decreases as the vessel heals. Accordingly, the vasodilator is desirably supplied over a period of about two to three weeks.
- trauma from angioplasty is not the only vessel injury which can cause vasospasm, and the device 10 may be introduced into vessels other than the coronary arteries, such as the aorta, carotid arteries, renal arteries, iliac arteries or peripheral arteries for the prevention of vasospasm in them.
- bioactive material in the present invention is delivered across the device 10 , and not by passage from an outside source through any lumen defined in the device 10 , such as through a catheter employed for conventional chemotherapy.
- the bioactive material of the present invention may, of course, be released from the device 10 into any lumen defined in it, and that lumen may carry some other agent to be delivered through it.
- Paclitaxel is a particularly preferred anti-cancer agent and/or anti-angiogenic agent as the bioactive material of the layer 18 .
- Paclitaxel is also a lipophilic bioactive material that is attracted by the lipids in the endothelial and smooth muscle wall cells of the vessel.
- the implantable medical device such as a stent of the present invention
- the stent maintains the bioactive material layer 18 in direct contact with the vessel wall.
- Paclitaxel is applied to a medical device such as a balloon which is used for delivering another medical device such as a stent to a treatment site.
- the surface 16 of the base material 14 of the structure 12 can be roughened or textured in any convenient manner, such as by etching.
- the surface 16 is roughened or textured by abrading, for example, by abrading with an abrasive grit 24 comprising at least one of sodium bicarbonate (USP), calcium carbonate, aluminum oxide, colmanite (calcium borate), crushed glass, crushed walnut shells, or mixtures of these or other abrasive particulates.
- USP sodium bicarbonate
- CaCO calcium carbonate
- aluminum oxide colmanite (calcium borate)
- crushed glass crushed walnut shells, or mixtures of these or other abrasive particulates.
- Such roughening or texturing is most easily carried out by placing the medical device 10 on a mandrel 20 in a position such that abrasive grit 24 delivered from a nozzle 22 impinges on the surface 16 .
- the initial surface of the base material prior to roughening or texturing may be smooth
- the abrading step is carried out with sodium bicarbonate (USP) having a nominal particle size of about 50 microns (50 ⁇ m), with approximately 50% greater than 40 microns (40 ⁇ m) and approximately 1% greater than 150 microns (150 ⁇ m).
- USP sodium bicarbonate
- Such abrading is preferably carried out with the sodium bicarbonate or other abrasive grit 24 delivered at a pressure under flow of about 5 to about 200 PSI (about 34 to about 1380 KPa), most preferably about 100 PSI (about 690 KPa).
- Such abrading is also preferably carried out with the sodium bicarbonate or other abrasive grit 24 delivered at a grit feed rate of about 1 to about 1000 g/min, most preferably about 10 to about 15 g/min.
- Spray plan 8 equally-spaced circumferential positions
- the folded balloon ends 30 and 32 extend beyond the end of the stent ends and are coated with lipophilic bioactive material for deposition on the vessel wall extending beyond the ends of the delivered stent.
- the balloon 26 is preferably of a polyamid material such as nylon 12 which is available from COOK, Inc., Bloomington, Ind.
- the balloon 26 is attached to a catheter shaft 38 , which includes a guide wire lumen as well as an inflation lumen for inflating the balloon.
- the lipophilic bioactive material layer is sprayed, posited, or disposed on the hydrophilic or slip coating layer 58 .
- the hydrophilic layer permits easier detachment or delivery of the lipophilic layer 28 when in contact with the cells of a vessel wall.
- FIG. 10 depicts the base and lipophilic material layers of the structure of FIG. 9 with an additional layer of bioactive material 28 sprayed, posited, or disposed therein.
- This configuration presents an alternative embodiment for delivering greater doses of the lipophilic bioactive material to the cells located on the surface of a vessel wall.
- the present invention is useful in the performance of various surgical procedures and in the manufacture of devices for the performance of various surgical procedures, and therefore finds applicability in human and veterinary medicine.
Abstract
Description
Claims (20)
Priority Applications (9)
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